Hi all,
A quick question with regard to line clearance. What is the regulatory guidance on line clearance? It is not very well highlighted in ISO 13485: 2003 but yet is a critical tool to prevent mix-ups and ensure traceability, etc. Can anyone point me to guidance docs/ regulatory docs for use in creating a policy?
All help greatly appreciated.
John M.
P.S. Thanks Al for your redirection. Much appreciated.

I think you're looking for the cGMP. As far as I recall it deals with lineclearance. You are quite right that it is essential to ensure a smooth and secure production so obviously ISO13485 don't deal with it in a timely and efficient manner

Hello all,
As I am currently working with a company that must address this issue for the first time in their 17 year history and with my experience I find that tying line clearance with ID and traceability suits the purpose just fine. As this is addressed in ISO as Prod ID traceability I think it helps to be thorough in implementation. In our case we are dealing with several different shaped machined parts...custom for the most part. I too must implement a line clearance procedure but one that will flow with machinists and their machined parts....pretty tricky when it comes to securing lots of parts or segregating them as they travel through the many processes in finishing the parts...Once I have the segregation issue worked out ...line clearance is easy. BUT I have to implement a general line clearance ASAP due to a customer audit that I must get closed out in less than two weeks....I have addressed all the other BIG issues already in the month and a half I have been on site....(including 4 validations that needed polishing while I was contracting from MA for the month I was packing and moving...but I have no doubt I will find something here that can help me in my quest. I hope my sharing will help and if I can provide greater insight on any topic more specific to your needs please let me know.
Best of luck

Hi all,
A quick question with regard to line clearance. What is the regulatory guidance on line clearance? It is not very well highlighted in ISO 13485: 2003 but yet is a critical tool to prevent mix-ups and ensure traceability, etc. Can anyone point me to guidance docs/ regulatory docs for use in creating a policy?
All help greatly appreciated.
John M.
P.S. Thanks Al for your redirection. Much appreciated.

Hi John,

Welcome to the Cove

Yes, Line Clearance is very much required as per FDA and is mentioned under "PRODUCTION SYSTEM" and "PACKAGING AND LABELING SYSTEM" in Compliance Guide . FDA insist on having a procedure for Line Clearance and Documentation resulting there from.

Though not explictly mentioned in ISO 13485, I feel it is mandatory as ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements.

ISO13485 does have specific requirements for traceability. Not every line in every company would need to be cleared, which is maybe why not more is stated in the issue, but I agree that some extra detail in the section would be useful.